Speeding Drug Development through State-of-the-Art Impurity Control Strategies

South San Francisco

10/31/2018

8:00am - 9:30am

We invite you to join us for a breakfast seminar geared specifically toward process chemists and analytical scientists. Enjoy a morning of coffee and chemistry in South San Francisco compliments of Regis Technologies. Regis is excited to host guest speaker, Dr. Steven Baertschi, for a special presentation on controlling impurities. Limited seating is available. RSVP by October 26th to save your seat. Complimentary parking is available.

Abstract: Development and implementation of impurity control strategies is a complicated, yet critical process necessary to ensure overall pharmaceutical product quality and patient safety. Existing guidelines for control of new impurities in drug substances and new drug products (ICH Q3A/Q3B, USP Chapters <476> & <1086>) apply to commercial products or products in late-stage clinical development (Phase 3). In addition, guidance for mutagenic impurities (ICH M7), which covers early clinical development through commercialization, is a relatively new guideline and questions regarding its implementation remain. The lack of regulatory guidance regarding impurity controls at early stages of clinical development (prior to Phase 3) provides both questions and opportunities for the development of effective control strategies. This talk will focus on risk-based, chemistry-driven approaches to speeding the development of organic impurity control strategies throughout clinical development. Relevant examples and references will be provided.